The Certified GMP Validation Specialist (CGVPS) course, developed and offered by CDG, is a comprehensive online self-study training and certification program designed to provide professionals with a deep and practical understanding of Good Manufacturing Practice (GMP) validation. This course is tailored for individuals involved in pharmaceutical, biopharmaceutical, biotechnology, and related regulated sectors where GMP compliance is a mandatory quality and regulatory requirement.

Validation is a cornerstone of GMP compliance, and its role is fundamental in ensuring that manufacturing systems, processes, equipment, facilities, laboratories, and computerized systems consistently perform as intended. The CGVPS course addresses the full scope of GMP validation, from conceptual principles to technical implementation, regulatory alignment, documentation, and lifecycle maintenance. It is intended for professionals seeking to expand their expertise in GMP validation and gain a recognized certification that strengthens their career credentials.

This course is delivered 100% online in a self-paced format, enabling learners to study on their own schedule without the constraints of live sessions or classroom attendance. Learners can progress through the material at their preferred speed, revisit modules as needed, and complete the course based on their personal availability and understanding. Whether a participant chooses to complete it within weeks or over a longer period, the course remains accessible until completion. Once the learner has completed all study content, they are required to take an online examination, and upon passing, will receive a digital certificate issued by CDG, acknowledging them as a Certified GMP Validation Specialist.

The CGVPS course has been meticulously designed to address both the theoretical and applied aspects of validation as required under GMP. It provides detailed coverage of validation concepts such as process validation, equipment qualification, cleaning validation, computer system validation (CSV), analytical method validation, and facility and utility qualification. The curriculum is aligned with international regulatory guidelines including those issued by the US FDA, EU GMP, WHO, ICH, and PIC/S, ensuring that the knowledge gained is globally relevant.

One of the course’s key strengths is its focus on the validation lifecycle approach, which is now a standard expectation in modern GMP systems. Learners are introduced to Stage 1 (Process Design), where the foundation for robust validation is laid through development studies, risk assessments, and identification of critical quality attributes (CQAs) and critical process parameters (CPPs). In Stage 2 (Process Qualification), they explore how to qualify equipment, facilities, and processes using structured protocols such as DQ (Design Qualification), IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification). The final phase, Stage 3 (Continued Process Verification), equips learners with the skills to monitor validated processes on an ongoing basis using real-time data, trending techniques, and statistical controls to ensure that a validated state is sustained over the product lifecycle.

Throughout the course, special emphasis is placed on documentation, traceability, and data integrity, which are critical components of any GMP validation effort. Participants will learn how to prepare and maintain validation master plans (VMP), validation protocols, summary reports, and audit-ready records. They will also understand the implications of poor validation practices, including potential regulatory findings, recalls, and risks to patient safety.

In addition to process validation, the course provides in-depth training in specialized areas including:

Cleaning validation, covering residue limits, swab/rinse recovery, cleaning agents, revalidation triggers, and lifecycle monitoring

Analytical method validation, focusing on method performance characteristics such as specificity, accuracy, precision, linearity, range, and robustness

Computer system validation (CSV) using GAMP 5 principles, user requirement specifications, functional specifications, audit trails, and electronic data integrity

Qualification of packaging, labeling, HVAC systems, cleanrooms, water systems, and compressed gases, which are essential utilities and support systems in GMP environments

Hold time studies, media fill validations, and equipment lifecycle management, ensuring learners are prepared for operational complexities in sterile and non-sterile manufacturing setups

The CGVPS course also covers risk-based validation approaches, applying ICH Q9 principles to prioritize validation activities and apply science-based justifications. Change control, deviation handling, and corrective and preventive action (CAPA) integration are thoroughly discussed to provide learners with a complete understanding of how validation interacts with quality systems.

Upon successful completion of the course and passing the final online exam, learners are awarded the Certified GMP Validation Specialist (CGVPS) certificate, which is digitally generated and verifiable. This certificate is a formal recognition of the candidate’s competence in understanding and applying GMP validation principles across a broad range of systems and scenarios.

This course is ideal for:

• Quality Assurance and Quality Control professionals
• Validation and Qualification specialists
• Manufacturing and Operations personnel
• Regulatory Affairs and Compliance officers
• Engineers, Scientists, and R&D staff
• Auditors, Consultants, and GMP Trainers

Whether you are looking to begin a career in GMP compliance, improve your current validation practices, or demonstrate your expertise to employers and regulatory bodies, the CGVPS certification from CDG provides a solid foundation and trusted credential. With the convenience of self-paced online learning, expert-designed content, and a globally applicable certification, this course is an essential professional development tool for today’s quality-driven pharmaceutical and life sciences workforce.

Join CDG’s Certified GMP Validation Specialist program and take the next step in your compliance career—anytime, anywhere. Enroll Now!